Elizabeth Sullivan

Extension Associate /

Process Authority

Dept. of Food Science

December 7, 2015

The NYS Food Venture Center:

Extension Outreach and Research

NYS Food Venture Center

• Mission: provide comprehensive technical assistance to farmers, entrepreneurs and food companies pursuing new food products for the marketplace, to enhance food safety and promote economic development

• Established in 1988, became a regional center through USDA grant in 2000 (Northeast Center for Food Entrepreneurship – NECFE)

• Funding: Cornell, state and federal grants, subsidized fees

The FVC Team• Dr. Olga Padilla-Zakour, Director and Process Authority• Elizabeth Sullivan, Extension Associate and Process Authority• Andy Humiston, Extension Support, extensive science experience• Shannon Prozeller, Extension Aid• Herb Cooley, “technical expert emeritus”, > 35 years in Food Science

On-going support from • Dr. Randy Worobo, Food Microbiology Expert• Chris Gerling, Extension Associate in wine and alcoholic foods

Education and Outreach

• Website, educational materials, workshops• Links to other Cornell, University resources

Provide lists of labs, co-packers, commercial kitchens, labeling design, nutrition labeling, packaging suppliers, etc.

• Provide links to consultants for Product Development

Product Safety and Stability• Expertise in fruit and vegetable based products• Review and Approve recipes for safety and stability and

issue Scheduled Processes/Product Reviews– Regulatory Compliance: state, FDA and USDA

• Direct Technical Support: one-on-one consultations, 99% via phone/email– Work with processors to tweak formulations –> processing

parameters, packaging preferences, available equipment, etc.– Troubleshoot/Evaluate processing concerns

Product Safety and Stability

• In 2013: 3500 client contacts; 412 business received assistance for commercialization of 1200 food products

• In 2014: 7,000 client contacts; 437 clients received assistance for commercialization of 1276 food products

YTD 2015 • 1001 scheduled processes• 262 amendments

• Over 670 samples analyzed

• States served:• New York (70%)• New England area if no • service available within state• Pennsylvania• New Jersey• Ohio• Others: CO, MN, MI, IL, FL, MD, etc.

Processing Authority Service – Ensure Safety and Regulatory Compliance of Foods

Based on regulations, a Processing Authority is a person or institution that has

o expert knowledge, o experience

o adequate facilities (equipment and resources)

to make determinations about the safety of a food process and formulation

Schedule Process

• Detailed procedure issued by a Processing Authority that includes:– Formulation– Critical Control Points – Processing steps– Storage, distribution, selling conditions/restrictions

• Required in New York and in many states for approval of most new food products; required by FDA for shelf-stable low acid, water-activity controlled and acidified foods

Example of a process authority

“schedule process” for an acidified food

*FDA required information

Science-based guidelines

*re-evaluating for new 2541e and 2541f

forms

Typical Small-Scale Fruit/Vegetable Based Food Products• Baked Goods• Confections• Sauces: BBQ Sauce, Hot Sauce, Pasta Sauces• Dressings• Pickles, Relish, Chutney• Jams & Jellies• Chocolate & Caramel Sauces

Increased client interest in:

• Simple syrups/cocktail syrups• Lacto-fermented foods (sour pickles, kimchi)• Kombucha, water kefir, SCOBY-produced beverages• Artisanal charcuterie– sausages, jerky, pastrami, etc.

Sample of Products Produced With FVC/NECFE Assistance

Research – The Basic Conflict

• Small-scale processors rely on quality (nutrition, color, ingredients, etc) to justify price BUT can rarely finance the research to support safety, stability of atypical processing methods

• Regulatory agencies increasingly require a)research or b) peer-reviewed literature as proof for things long considered common knowledge within field– What is acidified?– Is the processing adequate for safety? Stability?

Challenge: develop a body of research to support the majority of processing recommendations and requirements

Research• Graduate research:

– Acidification rate for pickled eggs under various conditions– D and z-values @ various pH values in acidified juice– Challenge study for cold-filled pickled eggs– Stability of acidified juice

Much research is focused on

intersection of Regulatory

requirements and processor

desires/realities

Research – Pickled Eggs

1. Acosta, O, XF Gao, EK Sullivan, OI Padilla-Zakour. 2014. Pickled Egg Production: Effect of Brine Acetic Acid Concentration and Packing Conditions on Acidification Rate. J. Food Prot, 77(5):788-795

• Acid diffuses through egg white very rapidly; slowly through yolk

• Acidification faster with hot fill brine, boiling water bath

• Higher concentration of acid in brine = faster acidification

• Texture changes are because of acidification rather than packing conditions

Research – Pickled Eggs

2. Sullivan, EK, DC Manns, JJ Churey, RW Worobo and OI Padilla-Zakour. 2013. Pickled Egg Production: Inactivation Rate of Salmonella, Escherichia coli O157:H7, Listeria monocytogenes, and Staphylococcus aureus during Acidification Step. J. Food Prot. 76(11): 1846-1853.

• 2% AA , equilibrium pH 4.0 - 5 days to 4.6 at yolk center; 41ºF; 13 days to equilibrium

• 1% AA , equilibrium pH 4.4 - 9 days to 4.6 at yolk center; 41ºF; 16 days to equilibrium

Research – Pickled Eggs

2. Pickled Egg Production continued• No pathogens detectable after 14 days• No difference in pathogen die-off rates between brines

with chemical preservative and those without• S. aureus survived refrigeration, died quickly once eggs

removed from refrigeration• 1% aa – 10-14 days to achieve non-detect.• 2% aa – E. coli O157:H7, L. monocytogenes and

Salmonella non-detect in 72 hours; S. aureus non-detect in 7 days (2 days after removal from refrigeration)

Research – Pickled Eggs

2. Pickled Egg Production conclusions• Pathogens begin to die off under refrigerated storage• Heat treatment (ambient temperature storage) required to

reach non-detect levels– 2% AA total system: particularly for S. aureus on

eggs; lids okay under refrigeration– 1% AA total system: all pathogens on eggs;

S. aureus on lids

Research

3. Usaga, J., RW Worobo, OI Padilla-Zakour. 2014. Thermal Resistance Parameters of Acid-Adapted and Unadapted Escherichia coli O157:H7 in Apple-Carrot Juice Blends: Effect of Organic Acids and pH. J. Food Prot. 77(4): 567-573.

• D- and z-values to determine lethality calculated for acidified juice at pH 3.3, 3.5, 3.7 and 4.5

• Samples pH adjusted through addition of lactic, acetic or malic acids; pH 4.5 through addition of NaOH.

Research

3. Thermal Resistance Parameters continued• E.coli more tolerant (D-values higher for given

temperature) in samples acidified with malic, followed by lactic and acetic acids

• D- and z- values given for fluid acidified food with pH values lower than 3.9.

• Pasteurization rather than commercial sterility

Research – Awaiting PublicationStability of acidified juices (pH 3.3, 3.5, 3.7) in PET, Glass, both w/ lid capable of hermetic seal, fill temps of 63, 71, 77ºC

Initial Results:• Large cooling difference between PET and Glass = very

different thermal treatment during hold time post sealing• Confirms acetic acid better against spoilage than malic

acid

Research – Awaiting PublicationStability of acidified juices (pH 3.3, 3.5, 3.7) in PET, Glass, both w/ lid capable of hermetic seal, fill temps of 63, 71, 77ºC

Positive results for:• Acetic acid/PET all pHs, fill temps (63, 71, 77ºC) • Malic acid/PET all pHs, fill temps 71, 77ºC• Acetic acid/Glass pH 3.3, fill temp 71, 77ºC

• Malic acid/Glass – no combo of pH/fill temp worked

More comprehensive Schedule

Process Documentation to Meet

FSMA Preventive Controls:

• Include hazard analysis per product

category

• Include controls for biological,

chemical and physical hazards

NEW DEVELOPMENTS & INITIATIVES

5. Review & Adjust

1. Identify Hazard2. Understand Cause

3. Implement Preventive Controls

4. Monitor Effectiveness

• Expanded use of pilot plant in partnership with the Cornell

Agriculture and Food Technology Park & Start-Up NY

• Small scale commercial production for tenants/members of the

Park

NEW DEVELOPMENTS & INITIATIVES

• Satellite office, lab and training room for the FVC/NECFE in

NYC

• Possible location in Brooklyn

NEW DEVELOPMENTS & INITIATIVES

• HPP Unit for process validation

NEW DEVELOPMENTS & INITIATIVES

Continued research leading to peer-reviewed publication relevant

to increased FDA scrutiny for Acidified, Water Activity Controlled

Foods

• ingredient buffer capacity and effect on pH

• hot hold time/temperatures for shelf stability

ONGOING INITIATIVES

Thank you very much for your time and interest

• For additional information:• Email: gah78@cornell.edu

(Andy Humiston)• Phone: 315-787-2273